QA Specialist II - Contract - Philadelphia, PA
Proclinical is seeking a QA Specialist II for a contract role based in Philadelphia, PA. This position focuses on quality assurance activities within the pharmaceutical and immuno-oncology space.
Primary Responsibilities:
The successful candidate will play a key role in ensuring compliance with regulatory standards, supporting manufacturing operations, and contributing to quality improvement initiatives.
Skills & Requirements:
- Experience in scientific laboratory and/or production environments.
- Knowledge of FDA GLP/cGMP requirements and PTC guidelines.
- Familiarity with EU cGMPs and MHRA Out-of-Specification guidance is a plus.
- Proficiency in root cause analysis techniques.
- Experience with writing, reviewing, and approving laboratory investigations, deviations, and CAPAs.
- Strong computer skills, including Microsoft Word, Excel, and Access.
- Ability to perform accurate calculations and record data legibly.
- Effective verbal and written communication skills.
- Team-oriented with strong interpersonal skills.
- Bachelor's degree in a science-related field or equivalent experience.
The QA Specialist II's responsibilities will be:
- Review and approve non-conforming events (NCE) and CAPAs.
- Conduct pre-review and approval of pre-executed batch records for assigned clients.
- Perform post-review of manufacturing (MFG) batch records as needed.
- Review and approve MFG Certificates of Analysis (COAs).
- Timely review of complex study files, including assay and process validations.
- Stay updated on GXP changes, including FDA, EU, and other regulatory guidance documents (e.g., ICH, ISPE).
- Collaborate with manufacturing management to provide quality perspectives on routine operations.
- Ensure project requirements are effectively translated into manufacturing records.
- Work with document reviewers to compile and review raw data, batch records, and test results.
- Investigate and explain observations or deviations as necessary.
- Write and revise Standard Operating Procedures (SOPs).
- Review and approve document change requests.
- Oversee equipment validation (IQ, OQ, PQ) and change control processes.
- Participate in quality and process improvement initiatives.
- Coordinate and execute manufacturing suite inspections.
- Support internal audits, client audits, supplier audits, and regulatory inspections.
- Act as a point of contact for on-site client visits and audits.
- Collaborate with project teams to design, set up, and execute projects.
- Facilitate timely and accurate completion of pre- and post-executed batch records.
- Contribute to departmental goals and overall operations.
- Perform job-specific tasks in compliance with applicable regulations and internal policies.
- Other duties as assigned.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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